Medical Device Quality Inspector

Medical Device Quality Inspector

Desired:
Experience with optical measurement machines or a CMM
Familiar with ISO13485 or ISO 9001

The Medical Device Quality Inspection group is responsible for assuring that materials, activities, processes, and specified conditions related to the daily device manufacturing, processing and packaging meet current GMP standards and comply with applicable procedures and standards such as to ensure the quality integrity of the product.

The medical device quality inspector inspects parts to specifications that are on a part drawing. This person will perform part inspections using measurement tools such as calipers, micrometers, gage pins, plug gages, and thread gages.
This person would also be trained to an ERP system; SAP to enter in acceptance data. Another system they would learn is the nonconforming material reports to enter failure data. I'd prefer someone who has material inspection experience as described and be able to work with computer based applications. They may not have SAP experience, but we will train. we are ISO 13485:2008 registered company as well as registered with the FDA. While this person may not have experience in a regulated environment they would be expected to follow procedures after being trained. We have a team environment and all of the team works together on supporting production which means being flexible on assignments. We also at times work overtime depending on production schedules and incoming part volumes.

Additional qualifications include:
High School diploma
Read and write in English
Basic math skills
Ability to use measurement devices such as calipers, thread gauges and micrometers to check whether materials or products meet standards
Ability to identify defects and flaws
Attention to detail
Ability to work in a fast paced team environment with minimal supervision
Work with Microsoft Word and Excel
Flexible in working overtime as needed #ZR

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